Skip to content

Resolute Onyx™ RONYX25022WRecalls & reported problems

Medtronic, Inc. · STENT RONYX25022W RESOLUTE ONYX 2.50X22 · Class 3 · Implant

All models of Resolute Onyx (101)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169602342), received between Jul 5, 2019 and Mar 8, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Burst Container or Vessel1
  • Detachment of Device or Device Component1
  • Material Deformation1
  • Use of Device Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 8, 2021Burst Container or Vessel; Detachment of Device or Device Component; Material Deformation; Burst Container or Vessel; Detachment of Device or Device Component; Material Deformation

    DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX OTW CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 80% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENTS BALLOON BURST DURING STENT DEPLOYMENT AT 6 ATM ON THE THIRD INFLATION. IT WAS ALSO REPORTED THAT THE DEVICE DETACHED DURING THE REMOVAL OF THE DEVICE. IT WAS STATED THAT THE DETACHED PORTION OF THE DEVICE WAS REMOVED FROM THE PATIENT WITHIN A TELESCOPE GUIDE EXTENSION CATHETER. THE DEVICE WAS NOT KINKED AND RESTRAIGHTENED DURING USE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11435484 ↗
  • MalfunctionJul 5, 2019Use of Device Problem; Use of Device Problem

    A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT THE STENT WAS IMPLANTED ((B)(6) 2019) 32 DAYS PAST IT'S EXPIRY DATE ((B)(6) 2019). THE PATIENT IS ALIVE WITH NO INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8763975 ↗

Other Coronary drug-eluting stent devices

All Coronary drug-eluting stent devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page